Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT01651494
Brief Summary:
This study will be a double-blind, randomized, placebo-controlled study of a single dose (20mg) of Influenza Antiviral DAS181-F04 for 3 days. The group of nine subjects will be randomly assigned to DAS181 or placebo at 2:1 ratios. Subjects will be admitted to the inpatient clinic at a minimum of the night prior to first dose. The subjects will stay in the inpatient clinic for the duration of dosing and one day after dosing, they will be required to come back for follow-up visits on study days 4, 6, 9, 16 (+/-1 day), 32 (+/-3 days), and 90 (+/-10 days). The safety parameters will include abnormal laboratory values, adverse events and clinical observations.
Detailed Description:
This study will be a double-blind, randomized, placebo-controlled study. The subjects will receive a single-dose treatment of DAS181-F04 or placebo at a targeted delivered dose of 20mg each day for three days. The subjects will be evaluated on the day before the initial dose (Day -1) and randomly assigned to DAS181-F04 or placebo in a 2:1 ratio. Subjects will be evaluated prior to dosing on Days 0, 1 and 2. Additional follow-up evaluations will occur one day after completion of dosing (Day 3) and on Days 4, 6, 9, 16 (+/-1 day), 32 (+/-3 days) and 90 (+/-10 days). The primary objective is to determine the safety and tolerability of DAS181-F04 encapsulated dry powder compared to placebo when administered by oral inhalation using a dry powder inhaler (DPI) in healthy adults. The secondary objective is to investigate the pharmacokinetic and immunologic profile of DAS181 encapsulated dry powder dose to dose and compared to placebo when administered by oral inhalation using a DPI in healthy adults. A total of 9 subjects, healthy male and female subjects, ages 18 to 45 years will be enrolled. Subjects will be randomized 2:1 ratio, wherein 6 subjects will receive the active drug and 3 subjects will receive placebo. Subjects may be replaced if a subject withdraws within 7 days (Day 9) after receipt of the final study drug dose.
Study:
NCT01651494
Study Brief:
Protocol Section:
NCT01651494